Medical training device

ABSTRACT

A medical training device with an improved clam shell type torso arrangement. An improved two-piece tiltable head feature, including mechanical mounting structure for secure attachment of an improved lung bag or face shield. The head also includes an improved nose feature to provide a more realistic representation of nasal cartilage, and an improved neck assembly. Additionally, an electro-mechanical indicator device is provided to show real time feedback of the CPR compression rate being administered by a student on the training manikin of the present application. The feedback by the device may be provided preferably by visual indicators, but may also have, or alternatively have, audio indicators or signals, such as words or sounds, to indicate whether or not the student is compressing within the preferred rate range, and/or the degree of variance in the student&#39;s compression sequences.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims priority from U.S. Provisional PatentApplication Ser. No. 60/713,276 filed Sep. 1, 2005.

FIELD OF INVENTION

The present application is directed to an improved medical trainingdevice, and more particularly to a medical training manikin havingimproved features and accessories.

BACKGROUND

Numerous solutions have been offered in the past to provide aninexpensive medical training manikin which can be used in a trainingenvironment for either a group of trainees or a single individual. It isdesired that such medical training manikins are lightweight for easytransportation to the training site, as well as simple and quick toassemble, readily able to be cleaned or otherwise maintained in asanitary condition, easy to use, and capable of substantially simulatingthe functions and responses of a human patient.

Prior art devices which have attempted to provide solutions to the aboveinclude U.S. Pat. Nos. 6,500,009, 5,330,514, 5,468,151, 4,984,987 and5,885,084.

SUMMARY OF THE INVENTION

The present medical training device provides a number of improvedfeatures over prior products. The present product has an improved clamshell type torso arrangement. An improved two-piece tiltable headfeature is also provided. A head may include mechanical mountingstructure for secure attachment of an improved lung bag or face shield.The head also includes an improved nose feature to provide a morerealistic representation of nasal cartilage, and an improved neckassembly. Additionally, an electro-mechanical indicator device isprovided to show real time feedback of the CPR compression rate beingadministered by a student on the training manikin of the presentapplication. The feedback by the device may be provided preferably byvisual indicators, but may also have, or alternatively have, audioindicators or signals, such as words or sounds, to indicate whether ornot the student is compressing within the preferred rate range, and/orthe degree of variance in the student's compression sequences. Theindicator device also includes an automatic on/off sleep feature whichis activated by use and non-use of the present training manikin.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the improved medical training device ofthe present application showing a feedback indicator device.

FIG. 2 is a perspective view of the improved medical training devicehaving mechanical mounting structure on the head for securing a lung bagor face shield.

FIG. 3 is a schematic perspective view of the improved medical trainingdevice showing a two-piece clam shell style torso, where one piece is anouter skin portion made of thin pliable material supported by asubstantially rigid frame, and a second piece is an inner compressiblecore material supporting a compression rate indicator device.

FIG. 4 illustrates a torso similar to FIG. 3, together with a schematic,perspective illustration of the head with a neck assembly and a lung bagprior to engagement with the torso.

FIG. 5 illustrates the engaged torso and head of the device of FIG. 4.

FIG. 6 is a schematic, perspective illustration of the improved medicaltraining device in an infant embodiment.

FIG. 7 is a schematic, perspective illustration of the infant embodimentof FIG. 6 with the pliable cover in an open position with respect to thetorso.

FIG. 8 is a schematic, perspective illustration of the head and neckassembly of the improved medical training device of the presentapplication.

FIG. 8A is a cut-away view of an improved nose structure taken along theline 8A-8A in FIG. 8.

FIGS. 9 and 10 are schematic side views of the improved medical trainingdevice schematically illustrating the pivoting or tilting movement ofthe face portion of the head to enable training of the jaw thrusttechnique.

FIGS. 11, 12 and 13 are schematic side and perspective illustrations ofthe installation of a lung bag which is secured to the face portion ofthe improved medical training device at posts or hooks protruding fromthe face portion.

FIG. 14 schematically illustrates a face shield which is mechanicallysecured to the face portion of the improved medical training device, andmay alternatively be secured over a lung bag.

FIG. 15 schematically illustrates an electrical circuit diagram for aCPR compression rate indicator of the present medical training device.

FIG. 16 is a partial side view, schematic cut-away illustrating theinternal sensors, bellows and electrical contacts used in connectionwith the CPR compression rate indicator of the present medical trainingdevice.

DETAILED DESCRIPTION

The present application provides an improved medical training device 10.A general view of the adult embodiment of the improved medical trainingproduct or device 10 is shown in FIGS. 1 to 5, and the infant embodimentis shown generally at reference 10′ in FIGS. 6 and 7. Unless otherwiseindicated, many features of the adult and infant embodiments are similarand will be not be distinguished in detail, other than by the use of aprime designation in connection with the infant embodiment.

The improved device 10 includes a torso which is a two-piece clam shellstyle torso 14. The improved two-piece torso 14 is shown in a variety ofpositions in FIGS. 3 to 5. One piece of the torso 14 comprises an outerskin portion 40 made of thin pliable material, which is preferably amolded elastomeric material. In the illustrated embodiment of FIGS. 1, 3to 5 and 7, the pliable skin material 40 is supported by a substantiallyrigid portion or frame 42. The rigid frame 42 is preferably manufacturedof a rigid molded plastic material. The frame 42 and skin 40 may besecured together by molding the two pieces together, or may bemechanically secured together, such as by an adhesive.

The second torso piece is an inner core portion 46 which is covered bythe outer pliable skin 40, as shown in FIGS. 1 and 6. The skin and corepieces of the torso 14 may be connected together at a hinge 44 locatedalong one side of the frame 42. The core portion 46 is preferably of acompressible core material, such as a polyurethane foam material, toenable simulated CPR compressions. The second core torso piece 46 maylikewise include a base frame 48 for supporting the core portion 46,which base frame 48 may be secured to the core 46 via adhesive. Theframes 42, 48 may be connected together at the hinge 44 along one sideof the rigid support portions or frames. As shown in FIG. 16, mechanical(such as posts 68, and a spring or bellows 74) and electrical componentsused to perform and measure compressions during operation of the manikintraining device, are provided internally of the core 46.

The torso 14 may include a variety of additional features, such asopenings for insertion of additional demonstration organs (not shown),such as for organ transplant trainings. Additional components, such as asimulated heart or lung to be compressed, are shown in FIGS. 6 and 7.

The use of a two-piece torso 14 allows for fast and easy opening andclosing of outer skin 40 for quick installation of a lung bag 50 whichenables simulation of lung and chest expansion, particularly through thepliable outer skin portion 40. As illustrated in the figures, thepliable outer skin portion 40 is molded to include simulated landmarkscommonly found on the human torso for use during student training andCPR performance. Additionally, the torso 14 opens to capture and securea head 12 at a neck assembly 30. The neck assembly 30 is illustrated ina position generally opposite the hinge 44. A neck assembly 30 of avariety of designs may be provided as shown in FIGS. 4-5 and 11-12.

The improved two-piece head 12 is provided with molded head pieces,where the front half or face portion 16 is movable/tiltable, and theback half or base head portion 38 is stationary. A pliable simulatedskin cover (not shown) may also be added to the face portion 16 wheredesired for additional cleanliness or maintenance considerations.Additionally, an improved nose simulation is also provided as best shownin FIGS. 8 and 8A. The nose includes a simulated rigid nose cartilageportion 22 with a removable pliable cover portion 24 over said simulatedrigid nose cartilage 24. The nose cartilage portion 22 is formed as apart of the rigid face portion 16, with the removable cover portion 24formed of pliable material with openings 25 simulating nostrils. Thecover portion 24 is snapped into place over the nose cartilage portion22 to simulate skin.

Pivot points 18, forming a pivot axis, are provided to interconnect thehead and face portions near simulated ears 19 located on opposing sidesof the base head portion 38, which is similar to the natural pivotlocation of the human head generally at the top of the spine. The use ofpivot points 18, and a single pivot axis, near the ears 19, eliminatesthe need for more complex multiple piece pivot designs that are oftennecessitated by movement of the back of the head.

The front half or face portion 16 of the present device pivots at thepivot points 18, which define the single pivot axis, or is tilted byeither a tilt of the forehead (pressing against the forehead) andlifting the chin as shown by the arrows in FIG. 10, or by a jaw linelift illustrated by the arrows in FIG. 9, which enables the training ofthe jaw thrust technique. In particular, the two pieces of the head maybe biased by a spring or weight positioned intermediate the two piecesof the head 12 and internally. The design is preferably such that thejaw of the front or face portion 16 must be moved to a certain level orposition before the forehead may be tilted back as provided by themechanical shape of the pivot mechanism.

The two-piece head pieces are shown in a variety of positions in FIGS.11 to 16. In the illustrated embodiments, a neck assembly 30 forattachment to the fixed head portion 38 is also provided. The lung bag50 also passes through the neck assembly 30 during engagement within thehead 12 and torso 14 of the improved medical training device 10. In theembodiments of FIGS. 2 and 8, the neck assembly 30 is providedintegrally with the back head portion 38 such that the lung bag 50 isthreaded through a mouth opening 28 in the face portion 16, through afixed neck assembly 30 and into the torso 14 positioned intermediate theskin 40 and core portion 46, as shown in FIG. 7.

In FIGS. 3 to 5 and 9 to 14, a base portion 34 of the neck assembly 30is provided as part of the fixed base head portion 38, and a secondportion is provided as a removable slider cover 32 having finger tabs33, which snaps into engagement with the base portion 34 of the neckassembly 30. In either embodiment, the neck assembly 30 provides anopening 36 for passage of the lung bag 50 intermediate the head 12 andtorso 14.

As shown in FIGS. 11 to 13, the lung bag 50 is made of thin-film polymermaterial. To make use of the present device, the lung bag 50 is insertedthrough the mouth opening 28 of the face portion 16 of the head 14,through any neck assembly 30, and laid on the compressible core portion46 of the torso 14 while the outer skin 40 is in an open position, asshown in FIGS. 3 to 4 and 7. The lung bag 50 is a sealed bag to beinflated for simulation of lung inflation, with a single opening formedas a mouth portion 51 of the lung bag 50. Two openings 52 provided onthe lung bag at the sides of the mouth portion 51, which openings 52 arefor attachment to protruding portions 26, such as posts or hooks,extending from the face portion 16 of the head 14. The lung bag 50 issecured to and held flush against the mouth area of face portion 16 bythe mechanical means of the holes or cuts 52 in the thin-film lung bagmaterial. Similar holes or cuts 56 may be provided in a face shieldbarrier 54 to secure the face shield 54 covering the mouth opening 28 inthe face portion 16, as shown in FIG. 15, or secured over the lung bag50 covering the mouth opening 51, such that two layers of material aremechanically secured to the face portion 15 using the protruding posts26. With both the lung bags and face shields of the present design, thethin-film material is secured in place flush to the face portion of themanikin which improves training efficacy by reducing interference of thematerial, reducing the need for repositioning of the material, andimproving the visual presence of the manikin during training.

Finally, the present device provides a novel CPR rate indicator 60,which is an electro-mechanical device that provides real time feedbackof CPR compression rate being administered by the student on thetraining manikin device 10, 10′. The feedback is provided directly byvisual indicators and indicates whether or not the student iscompressing within the preferred compression rate range. Also, theindicator 60 may inform the student concerning what degree of variancethere is in the compressions being administered. Indications may beprovided as colored illuminated indicators, a numeric readout, or othervisual methods. The CPR rate indicator may be provided as an add onmodule which is integrated within or connected to an existing manikinproduct so as to be visually accessible to the student while CPR isbeing performed. As shown in FIGS. 1 and 3, the CPR rate indicator 60 isprovided integrally with the torso 14. A window or opening 62 may beprovided through the skin 40 and core portion 46 to enable viewing ofthe indicator 60 during use of the present training device.Alternatively, the indicator 60 may be provided as an original equipmentfeature to the manikin product 10, 10′. Where illuminated indicators 64are provided, they may be color coded to convey the level of studentperformance, e.g. red 64 a is poor, for example, less than 60compressions per minute; yellow 64 b is fair, for example, less than 80but greater than 60 compressions per minute; green 64 c is acceptable,for example, less than 100 but greater than 80 compressions per minute;the illumination of both green lights 64 c is a preferred performance,for example, 100 or more compressions per minute; and if desired,illumination and flashing of both green lights may be a more preferredperformance rate. The indication may be provided by colored/illuminatedindicators 64 a-c, such as LED's, a numeric readout, or other visualmethod, as well as by audio signals, such as beeps or tonal sounds.Audio signals may be provided as negative sounds, more positive sounds,most positive sounds and double positive sounds, to convey the desiredrate performance information. The indicator module 60 is preferablyintegrated within, or connected to, the manikin 10 to be visuallyaccessible to the student while CPR is being performed on the manikintraining device.

The CPR rate indicator 60 of the present application is preferablydesired as a visual training feature, which is passive and, unlike audiofeedback, does not interfere with the training exercise. However, itshould be understood that audio feedback may have additionaldesirability under certain training circumstances. Additionally, thevisual feedback is preferred over prior art metronome type timingdevices which the student attempts to follow and match repeating audiblesignals that represent the desired frequency of compression. Byremaining a passive feature, the visual indicators can be ignored untilit is desired by the student or instructor. Further, the real timefeedback regarding the compression rate performed is believed superiorto other methods which record the compression rate, but the record canonly be reviewed after the training exercise is completed. With thepresent rate indicator device 60, the student can view the visualindicators 64 while the compressions are in progress, and makeconcurrent adjustments and improve training performance during theexercise. Also, the CPR rate indicator 60 may be configured to respondwith positive visual feedback only when both the compression rate beingperformed by the student and the depth of compression into the coreportion 46 are properly achieved.

FIG. 15 provides a schematic illustration of the electrical circuit ofthe CPR rate indicator 60, which includes a conventional microprocessorunit 70 for recording and calculating the desired measurementsdescribed, the desired visual indicators 64 a-c, audio indicators,controllers, such as automatic on and off controls, and a power supply.The device is battery operated, with an operating voltage range ofbetween 2.20VDC and 5.5VDC, meaning that either 2 or 3 conventionalbatteries may optionally be designed for use. The indicator 60 ispreferably provided as a series of LED or other lights which would belocated at any position which is visible to the student during theapplication of compressions to the manikin, but preferably would beprovided within a slot or window 62 positioned near the shoulder of themanikin device 10 as shown in FIGS. 1 and 3.

Upon approaching the present manikin device having a CPR compressionrate indicator 60, the indicator may be in the off mode. Upon an initialcompression such that the sensor 66 engages the electrical contacts 67,68, the rate indicator is automatically moved to on mode of operation.During initial student compressions on the manikin device 10, 10′, thevisual display would only provide a red light 64 a. The indicator 60waits during the initial compressions until the student begins toperform at a regular compression speed. After a few data points arecollected using sensors 66 interconnected with the indicator device 60,a real time moving average of the speed of compressions is measured andcalculated by the microprocessor unit 70. Later during the compressionexercise, a different number of points are collected for averaging. Tocollect such compression data, the electrical sensor 66 is provided asshown in FIG. 16 at the center of the manikin torso 14 with a wirecontact 67 extending to the indicator module 60 for recording thenumber, speed and depth of compressions. The electrical sensors 66 maybe provided for engagement with posts 68 supporting the wire contact 67.The posts 68 are of a specific height such that engagement of thecontact with the posts by the student ensures that the desiredcompression depth has been achieved by the student to simulate heartcompression. After the last compression is sensed by the sensor 66, atimer within the indicator 60, generally shown within the microprocessor70 in FIG. 15, is activated which may be customized to a desired timeperiod. After the passage of the desired time, if no compressions aresensed, the indicator 60 is automatically moved to the off or sleepmode. In sleep mode, the device draws only about 1 micro Amp (μA) ofcurrent. Thus, the use of such a novel timer and sleep mode in theindicator 60 enables the present manikin device 10, 10′ to achievelonger battery life. The use of the timer is ideal in a teachingenvironment, since an instructor or student need not specifically turnthe manikin device on or off, as the device 60 is able to wake itself upfrom a low power consumption sleep mode. In the illustrated preferredembodiment, the training device does not include an on/off switch.

The CPR indicator 60 must accurately display the rate of CPRcompressions performed on the device 10, 10′, thus a microcontroller(MCU) is preferred in the illustrated circuit of FIG. 15. Since thecompression rate is a function of time, the clock source must be isaccurate and a resonator is preferable over a simple resistor/capacitornetwork, which has very wide tolerances and in many cases is alsotemperature dependent. An oscillator network is connected to pins 13 and14 of the microcontroller as shown in FIG. 15. Because there is noon/off switch in the circuit, it is technically always powered by thebatteries, and low power consumption of 1 uA during sleep mode isessential. A metal-oxide semiconductor field-effect transducer or MOSFETis preferred in the current design for reverse battery protection, as inFIG. 15, since, unlike a diode, the MOSFET minimizes the voltage dropacross it to maximize run time.

Once the device is in sleep mode, it is activated or reactivated whenthe bellows 74 is pressed at least one time. Pressing the bellows 74,closes a set of electrical contacts across the bell1 and bell2connection points shown in FIG. 15, and the microcontroller is awakenedfrom sleep mode using wakeup pin 15. Pin 9 is provided as an interruptpin to measure the time between each compression (which is the closingof a switch). A minimum of two compressions are required to be madebefore a compression rate may be calculated. After the secondcompression, the rate will be displayed using the LED's, which isgenerally the red LED 64 a. The LED's which are later illuminated dependon the very last two compressions which are received. When thecompressions stop, the microcontroller detects that the rate has fallenout of range or specification, and the red LED 64 a is illuminated. Ifno more compressions are made, the circuit moves to sleep mode and allvisual indicators 64 are turned off.

Although the medical training device of the present application has beendescribed in detail sufficient for one of ordinary skill in the art topractice the invention, it should be understood that various changes,substitutions and alterations may be made without departing from thespirit or scope of the device as defined in the attached claims.Moreover, the scope of the present device is not intended to be limitedto the specific embodiments described here, which are provided by way ofexample. As one of ordinary skill in the art will readily appreciatefrom the disclosure of the present device and its embodiments, othercomponents and means presently existing or later to be developed thatperform substantially the same function to achieve substantially thesame result as those of the corresponding embodiments described here,may be utilized according to the present application. Accordingly, theappended claims are intended to include within their scope such othercomponents or means.

We claim:
 1. An improved medical training device comprising, a) a torsoportion having a compressible core section and a removable pliable coversection, which core and cover sections are interconnected; b) a headportion interconnected with said torso portion, and having a fixed,non-movable, back half section and a movable front half face sectionwhich are pivotably interconnected near simulated ear sections; c)attachment portions located on said front face section and projectingtherefrom for attachment of a lung bag or a face shield; and d) a CPRrate indicator, integral with the device, for directly providing realtime feed back to a person being trained on said device of the rate ofCPR compressions being performed.
 2. A training manikin comprising, a) atorso portion having a core section comprising a continuous volumefilled by a compressible material that is compressed during operation ofthe manikin, and a removable pliable cover section, each substantiallysurrounded by a rigid frame member and said core and cover sections areinterconnected along one portion of each of said rigid frame members; b)a head portion interconnected with said torso portion, and having anon-movable, fixed back half section and a movable front half facesection which are pivotably interconnected; and c) an integral CPR rateindicator module comprising at least two indicators for providing realtime feedback to a student of their rate of CPR compressions during atraining exercise and wherein the module includes an automatic power onfeature which is prompted to turn the module power to on mode by aninitial CPR compression.
 3. The training manikin of claim 2 wherein saidcore and cover sections of said torso portion are interconnected at apivoting hinge located on one portion of each of said rigid framemembers.
 4. A training manikin comprising, a) a torso portion having acore section comprising a continuous volume filled by a compressiblematerial that is compressed during operation of the manikin, and aremovable pliable cover section, each substantially surrounded by arigid frame member and said core and cover sections are interconnectedalong one portion of each of said rigid frame members; b) a pivotablehead portion interconnected with said torso portion; and c) an integralCPR rate indicator module comprising at least two indicators forproviding real time feedback to a student of their rate of CPRcompressions during a training exercise, and wherein the module includesan automatic power on feature which is prompted to turn the module powerto on mode by an initial CPR compression.
 5. The training manikin ofclaim 4 with the CPR rate indicator module further comprising threedifferent indicators for providing real time feedback of CPR compressionrates.
 6. The training manikin of claim 4 or 5 wherein the CPR rateindicator module indicators are visual indicators or audio indicators.7. The training manikin of claim 6 wherein the CPR rate indicator modulevisual indicators are colored red, yellow and/or green lights.
 8. Animproved medical training device comprising, a) a torso portion having acompressible core section and a removable pliable cover section, whichcore and cover sections are interconnected; b) a head portioninterconnected with said torso portion, and having a fixed, non-movable,back half section and a movable front half face section which arepivotably interconnected near simulated ear sections; c) attachmentportions located on said front face section and projecting therefrom forattachment of a lung bag or a face shield; and d) a CPR rate indicatormodule integral with the device having at least two indicators fordirectly providing real time feed back to a person being trained on saiddevice of the rate of CPR compressions being performed during a trainingexercise, and the indicator module includes an automatic on featurewhich is prompted to the on mode by a CPR compression.
 9. An improvedmedical training device comprising, a) a torso portion having acompressible core section and a removable pliable cover section, whichcore and cover sections are interconnected; b) a head portioninterconnected with said torso portion, and having a fixed, non-movable,back half section and a movable front half face section which arepivotably interconnected near simulated ear sections; c) attachmentportions located on said front face section and projecting therefrom forattachment of a lung bag or a face shield; and d) a CPR rate indicator,integral with the device, for directly providing real time feed back toa person being trained on said device of the rate of CPR compressionsbeing performed, with the CPR rate indicator being positioned forviewing during performance of CPR compressions through a window formedin the device.
 10. An improved medical training device comprising, a) atorso portion having a compressible core section and a removable pliablecover section, which core and cover sections are interconnected; b) ahead portion interconnected with said torso portion, and having a fixed,non-movable, back half section and a movable front half face sectionwhich are pivotably interconnected near simulated ear sections; c)attachment portions located on said front face section and projectingtherefrom for attachment of a lung bag or a face shield; and d) a CPRrate indicator, integral with the device, for directly providing realtime feed back to a person being trained on said device of the rate ofCPR compressions being performed, with the CPR rate indicator positionedfor viewing during performance of CPR compressions through an openingformed in the removable pliable cover section of the torso portion ofthe device.